Events

Recall of Device Recall Manual Wheelchairs with Transit System Option

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Sunrise Medical Inc.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    51260
  • Event Risk Class
    Class 2
  • Event Number
    Z-0831-2011
  • Event Initiated Date
    2009-02-02
  • Event Date Posted
    2010-12-28
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2011-01-03
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=79491
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Mechanical wheelchair - Product Code IOR
  • Reason
    The stabilizer bar was inadvertently omitted during the manufacturing process.
  • Action
    An Urgent: Medical Device Correction letter, dated February 2009, with certified return receipt was sent to customers in the United States; Canadian consignees were notified via e-mail. The letter identified the affected product and the reason for the recall. The letters asked customers to contact their Quickie dealer to make arrangements to have their device wheelchair corrected at no charge and to also verify their wheelchair serial number on the form. Questions should be directed towards their dealer or Sunrise Medical at 800-456-8168.

Device

Device Recall Manual Wheelchairs with Transit System Option
  • Model / Serial
    Serial Numbers:  LXI-034554, LXI-034697, LXI-034694, LXI-034500, LXI-034609, LXI-034740, and  LXI-034741.
  • Product Classification
    Physical Medicine Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution -- United States and Canada.
  • Product Description
    Manual Wheelchairs with Transit System Option, || Model: Quickie LXI (EILXI), || Product is manufactured and distributed by Sunrise Medical, Inc. Fresno, CA || Intended to provide mobility to persons restricted to a sitting position and are unable to transfer from their wheelchairs when traveling in motor vehicles, the wheelchair must serve as a vehicle seat.
  • Manufacturer
    Sunrise Medical Inc

Manufacturer

Sunrise Medical Inc
  • Manufacturer Address
    Sunrise Medical Inc, 2842 N Business Park Ave, Fresno CA 93727-1328
  • Source
    USFDA